Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027160711

FEI Number

3027160711

Entity Name

MEDIPIXEL, INC.

City/State/Country

Gangnam-gu Seoul, KR

Establishment Address

3/F 22 Teheran-ro 108-gil, Gangnam-gu Seoul 06174, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medipixel, Inc. (Owner Number: 10087806)

Owner / Operator Contact Address

3/F 22 Teheran-ro 108-gil, Gangnam-gu, KR-11 06174, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222036

PMA Number

N/A

All Registered Proprietary Names

Medipixel XA MPXA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-04-12

Official Correspondent

No official correspondent registered.

US Agent Details

Eric Min Email: Eric.Min@medipixel.io Phone: (802) 8816960

Related Public Records

Same Entity

Medipixel, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

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3042852277	REMEDY LOGIC	New York, NY, US
3027986210	MRIGUIDANCE B.V.	Utrecht, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027160711. Last updated year: 2026. Please use registration number 3027160711 when referencing this establishment in official correspondence.